New Regulatory Affairs Professional Job in Newark, DE!
Position Title: Regulatory Affairs Professional

Position Number: 340743

Location: Newark, DE 19702

Position Type: Long Term Contract

Required Skill Set:

Assembly, Microsoft Office, Regulatory Affairs, SharePoint

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Regulatory Affairs Professional
Location: Newark, DE 19702
Duration: 12+ Months
Schedule: Shift 1; M-F (8:00 AM - 4:30 PM)

Description:
• Analyzes the requirements and prepares product related regulatory submissions.
• Analyzes the requirements and prepares product related regulatory submissions for In-Vitro Diagnostics (IVD) products.
• Identifies, analyzes and implements country specific requirements necessary for IVD product related submissions.
• Plans and prepares product related submissions with Client internal (e.g. Regional Units)
• Participates in regulatory projects or acts as a member of the project steering group.
• Initiates and escalates necessary activities if deviations are identified.
• Needs to consider processes and results, generated in other workflows and disciplines, implies conditions and environments, and values significance to contribute effectively to team results.
• Needs experienced level of analytical and distinctive conceptual skills to solve issues given, which may differ in size and nature 3-5 years.
• Thorough professional know-how in IVD product technical dossier assembly, MS office applications (i.e. SharePoint).
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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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About Rose
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